Last updated on December 2018

A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study


Brief description of study

This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months.

Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:

  • DE-117 Ophthalmic Solution once daily and Vehicle once daily, or
  • Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3.

Clinical Study Identifier: NCT03691662

Contact Investigators or Research Sites near you

Start Over

Santen Inc Clinical Operations

Arizona Eye Center
Chandler, AZ United States
  Connect »

Santen Inc Clinical Operations

M & M Eye Institute
Prescott, AZ United States
  Connect »

Santen Inc Clinical Operations

Global Research Management
Glendale, CA United States
  Connect »

Santen Inc Clinical Operations

United Medical Research Inst
Inglewood, CA United States
  Connect »

Santen Inc Clinical Operations

Eye Research Foundation
Newport Beach, CA United States
  Connect »

Santen Inc Clinical Operations

North Bay Eye Associates Inc.
Petaluma, CA United States
  Connect »

Santen Inc Clinical Operations

Arch Health Medical Group
Poway, CA United States
  Connect »

Santen Inc Clinical Operations

Sacramento Eye Consultants
Sacramento, CA United States
  Connect »

Santen Inc Clinical Operations

AdvanceMed Clinical Research
San Diego, CA United States
  Connect »

Santen Inc Clinical Operations

Michael K. Tran, MD, Inc.
Westminster, CA United States
  Connect »

Santen Inc Clinical Operations

Haas Vision Center
Colorado Springs, CO United States
  Connect »

Santen Inc Clinical Operations

Florida Ophthalmic Institute
Gainesville, FL United States
  Connect »

Santen Inc Clinical Operations

St. Michaels Eye Laser Institute
Largo, FL United States
  Connect »

Santen Inc Clinical Operations

International Eye Associates PA
Ormond Beach, FL United States
  Connect »

Santen Inc Clinical Operations

East Florida Eye Institute
Stuart, FL United States
  Connect »

Santen Inc Clinical Operations

Clayton Eye Clinical Research, LLC
Morrow, GA United States
  Connect »

Santen Inc Clinical Operations

Seidenberg Protzko Eye Associates
Havre De Grace, MD United States
  Connect »

Santen Inc Clinical Operations

Great Lakes Eye Care P.C
Saint Joseph, MI United States
  Connect »

Santen Inc Clinical Operations

Discover Vision Centers
Independence, MO United States
  Connect »

Santen Inc Clinical Operations

Silverstein Eye Centers
Kansas City, MO United States
  Connect »

Santen Inc Clinical Operations

Comprehensive Eye Care Ltd.
Washington, MO United States
  Connect »

Santen Inc Clinical Operations

AdvanceMed Clinical Research
Las Vegas, NV United States
  Connect »

Santen Inc Clinical Operations

New York Eye Infirmary of Mount Sinai
New York, NY United States
  Connect »

Santen Inc Clinical Operations

Rochester Ophthalmological Group, PC
Rochester, NY United States
  Connect »

Santen Inc Clinical Operations

Asheville Eye Associates
Asheville, NC United States
  Connect »

Santen Inc Clinical Operations

Total Eye Care PA
Memphis, TN United States
  Connect »

Santen Inc Clinical Operations

VRF Eye Specialty Group
Memphis, TN United States
  Connect »

Santen Inc Clinical Operations

Glaucoma Associates of Texas
Dallas, TX United States
  Connect »

Santen Inc Clinical Operations

Houston Eye Associates HEA - Gramercy Location
Houston, TX United States
  Connect »

Santen Inc Clinical Operations

Baylor College of Medicine Alkek Eye Center
Houston, TX United States
  Connect »

Santen Inc Clinical Operations

The Eye Clinic of Texas
League City, TX United States
  Connect »

Santen Inc Clinical Operations

Medical Center Ophthalmology Associates
San Antonio, TX United States
  Connect »

Santen Inc Clinical Operations

Stacy R. Smith M.D. P.C.
Salt Lake City, UT United States
  Connect »

Santen Inc Clinical Operations

Vistar Eye Center
Roanoke, VA United States
  Connect »

Santen Inc Clinical Operations

Tidewater Clinical Research
Virginia Beach, VA United States
  Connect »

Santen Inc Clinical Operations

University of California San Francisco
San Francisco, CA United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.